Animas Corporation Receives FDA 510(k) Clearance
For its Diabetes Management Software System
Frazer, PA - June 19, 2003 - Animas Corporation, a manufacturer of insulin infusion pumps and other products for patients with insulin-requiring diabetes, announced today that it has received US Food and Drug Administration (FDA) 510(k) clearance to market ezManager Plus.
ezManager Plus, the first software system of its kind to receive FDA 510(k) clearance, differs from other available systems with its comprehensive food database, carbohydrate calculator, and ability to accept download information from both the Animas IR 1000 insulin pump and a variety of blood glucose meters.
This software system, with both a Palm-OS and desktop module, is designed to help people better manage their diabetes and help reduce the time healthcare professionals need to spend helping patients manage diabetes. With this intuitive program, patients can:
- Access a database of more than 3,000 different foods, including fast food restaurants and customized favorites,
- Record daily activity on a personal digital assistant (PDA),
- Automatically calculate insulin needs for carbohydrate intake and blood glucose readings,
- Download and electronically send insulin pump history, blood glucose meter and PDA records, and
- Do trending analysis and obtain other statistical analysis.
Commenting on the FDA clearance, Dr. Katherine Crothall, Animas' CEO said, "Managing diabetes properly is very time-intensive for patients and their healthcare teams. Patients need to adjust their insulin intake based upon the carbohydrate content of their meal and current blood glucose readings, necessitating patients thumbing through food databases and performing multi-step computations. Many patients simply make wild guesses. ezManager Plus removes much of the guesswork and significantly simplifies the time-intensive computations.
"We are also committed to developing tools that reduce the strain on the already over-burdened healthcare system. The reports available from ezManager Plus give patients and the healthcare team a comprehensive view of important parameters of diabetes management and allow healthcare professionals to focus more efficiently on developing treatment plans for their patients," Dr. Crothall explains.
About Animas Corporation: Animas, a leading maker of insulin infusion pumps and related products, is dedicated to improving diabetes management and making insulin pump therapy easier for patients with insulin-requiring diabetes and healthcare professionals through product innovation, exemplary customer support and superior customer education. For more information on Animas, visit www.animascorp.com or call Animas Corporation at 877-937-7867.
For Immediate Release
Contact: Mindy Cooper
610-644-8990, ext. 1157
[ View the Press Release PDF Format ]
Last Updated: Friday June 20, 2003 21:46:53
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